Name: Oracle Argus Safety Essentials
SKU: 225042
Availability: InStock

Description

Oracle Argus Safety Essentials is a online eLearning course that covers the basic and advanced concepts of managing drug safety data using the Oracle Argus Safety application. The course starts with an overview of Oracle Argus Safety 8.1.1 and then covers a more detailed look at the various database features, case entry, workflow and reporting. It is intended for students and clinical research professional who are willing to make a career in Pharmacovigilance using the Oracle Argus platform.

The course includes hands-on practical training on Oracle Argus Safety software used as a de-facto standard for managing drug safety data

The program is made up of 1 modules, 8 topics and 9 Quizzes. It first covers the pre-requite topics on Pharmacovigilance and the takes you through the process of navigating the Oracle Argus Safety application. It then covers all the pharmacovigilance tasks performed in Oracle Argus Safety including Case entry, Case Triage, Medical coding, Medical review, Narrative writing, Quality control and Reporting.

On completing your enrolment for the Oracle Argus Safety Essentials program you will instantly get access to our online learning portal.

Looking for a course that includes 24×7 access to Oracle Argus Safety software? Check out this course

Find more information about the Oracle Argus Safety application – What is Oracle Argus Safety

Key Features

Training on actual Cases used in the industry
Course Instructor support via Email
Full access to e-Learning Portal containing Recorded Lectures.

Curriculum

Module 0 – Principles of Pharmacovigilance

General Overview of Pharmacovigilance
History and aim of Pharmacovigilance
Drug dependence
Vaccine Vigilance
Principles of Signal Detection in Pharmacovigilance
Communication in Pharmacovigilance
Post-Marketing Surveillance

Chapter 1 – Overview and Navigation

Process of Logging in
User Interface and Navigation
Functionality of User Interface Elements

Chapter 2 – Overview of Argus Menus

Business Process Workflow
Active Cases and Case actions
Worklist
Reports
Dashboard and Utilities

Chapter 3 – Case Form Features

Tabs and Fields of Case Form
Management of cases using Case Form fields

Chapter 4 – Drug and Event Coding

Coding Terms and MedDRA Browser
Drug and Event Coding using MedDRA and WHODD

Chapter 5 – Case Entry and Processing

Case Management Workflow
Case Processing – Spontaneous case
Case Processing – Sponsored Trial case

Chapter 6 – Advanced Conditions

Overview of Advanced Conditions
Building Complex Queries

Chapter 7 – Reporting and Submissions

Reporting Capabilities of Argus Safety
Periodic Safety Update Reports (PSUR)
Clinical Trial Periodic Reports (CTPR)
IND and NDA Reports
Case Data Analysis, Case Listing, CIOMS II Line Listing

Course Completion

Final Assessment
Course Certification

Certification

At the end of the course, students will be awarded a certificate of completion.

Duration

The duration of this program is 2 months.

You will have access to the course for the duration of the program.

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